Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

Duangtip Tiacharoen; Rojjanee Lertbunrian; Jarin Veawpanich; Nattanicha Suppalarkbunlue; Nattachai Anantasit

doi:10.5005/jp-journals-10071-23465

Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

Indian J Crit Care Med. 2020 Jun;24(6):451-458. doi: 10.5005/jp-journals-10071-23465.

Authors

Duangtip Tiacharoen¹, Rojjanee Lertbunrian², Jarin Veawpanich², Nattanicha Suppalarkbunlue³, Nattachai Anantasit²

Affiliations

¹ Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Division of Pediatric Critical Care, Department of Pediatrics, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
² Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
³ Clinical Pharmacy Department, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Abstract

Aims: The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children.

Materials and methods: This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups.

Results: Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group (p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group (p value = 0.016).

Conclusion: The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol.

Clinicaltrialsgov identifier: NCT03018977.

How to cite this article: Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.

Keywords: Benzodiazepine; Critically ill children; ICU sedation; Opioid; Weaning; Withdrawal syndrome.

Associated data

ClinicalTrials.gov/NCT03018977